FORT WORTH, Tx. (AP) – Mike Bowen’s warehouse outside Fort Worth, Texas, was piled high with cases of medical-grade N95 face masks. His company, Prestige Ameritech, can churn out 1 million masks every four days, but he doesn’t have orders for nearly that many. So he recently got approval from the government to export them.
“I’m drowning in these respirators,” Bowen said.
On the same day 1000 miles (1,600 kilometers) north, Mary Turner, a COVID-19 intensive care nurse at a hospital outside Minneapolis, strapped on the one disposable N-95 respirator allotted for her entire shift.
Before the coronavirus pandemic, Turner would have thrown out her mask and grabbed a new one after each patient to prevent the spread of disease. But on this day, she’ll wear that mask from one infected person to the next because N95s — they filter out 95% of infectious particles — have supposedly been in short supply since last March.
Turner’s employer, North Memorial Health, said in a statement that supplies have stabilized, but the company is still limiting use because “we must remain mindful of that supply” to ensure everyone’s safety.
One year into the COVID-19 pandemic, many millions of N95 masks are pouring out of American factories and heading into storage. Yet doctors and nurses like Turner say there still aren’t nearly enough in the “ICU rooms with high-flow oxygen and COVID germs all over.”
While supply and demand issues surrounding N95 respirators are well-documented, until now the reasons for this discrepancy have been unclear.
The logistical breakdown is rooted in federal failures over the past year to coordinate supply chains and provide hospitals with clear rules about how to manage their medical equipment.
Internal government emails obtained by The Associated Press show there were deliberate decisions to withhold vital information about new mask manufacturers and availability. Exclusive trade data and interviews with manufacturers, hospital procurement officials and frontline medical workers reveal a communication breakdown — not an actual shortage — that is depriving doctors, nurses, paramedics and other people risking exposure to COVID-19 of first-rate protection.
Before the pandemic, medical providers followed manufacturer and government guidelines that called for N95s to be discarded after each use, largely to protect doctors and nurses from catching infectious diseases themselves. As N95s ran short, the Centers for Disease Control and Prevention modified those guidelines to allow for extended use and reuse only if supplies are “depleted,” a term left undefined.
Hospitals have responded in a variety of ways, the AP has found. Some are back to pre-COVID-19, one-use-per-patient N95 protocols, but most are doling out one mask a day or fewer to each employee. Many hospital procurement officers say they are relying on CDC guidelines for depleted supplies, even if their own stockpiles are robust.
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Chester “Trey” Moeller, a political appointee who served as the CDC’s deputy chief of staff until President Joe Biden’s inauguration last month, said efforts to increase U.S. mask production were successful, but there has since been a federal breakdown in connecting those who need them with this new supply.
“We are forcing our health care industry to reuse sanitized N95s or even worse, wear one N95 all day long,” he said.
Before the pandemic tore through the U.S., the demand for N95 masks was 1.7 billion per year, with 80% going to industrial uses and 20% into medical, trade groups say. In 2021, demand for N95 masks for medical use is estimated by industry sources to be 5.7 billion.
With the increased demand and prodding from the federal government, U.S. manufacturers stepped in. Bowen’s company, Prestige Ameritech, boosted production from 75,000 N95 respirators a month to almost 10 million during the COVID-19 pandemic.
Still, many hospitals are building their stockpiles over fears of a future surge, and restricting the number given directly to health care workers.
The AP spoke with a dozen procurement officers who buy supplies for more than 300 hospitals across the U.S. All said they have enough N95s now, between two and 12 months worth, sitting in storage.
Even so, all but two of those hospital systems are limiting their doctors, nurses and other workers to one mask per day, or even one per week. Some say they are waiting for the supply to grow even more, while others say they never plan to go back to pre-COVID-19 usage.
Dean Weber, vice president of corporate supply chain management for Sioux Falls, South Dakota, Sanford Health, said the one-N95-per-patient guidelines were established with the help of manufacturers.
“You know, the mask manufacturers are in the business of selling masks,” Weber said. He said he prioritizes safety over cost, but he doesn’t believe these respirators need to be tossed after each use. “We were all, in fact, you know, just infatuated with an N95.”
But John Wright, vice president of supply chains for Salt Lake City-based Intermountain Healthcare, says reusing masks or wearing them longer “would not be appropriate” once they have enough supplies. He hopes his 23 hospitals and hundreds of clinics will be back to single use within two weeks.
As the coronavirus spread through spring and summer, demand for N95 masks surged to unprecedented levels and the respirators disappeared from stockpiles and distributors’ shelves. Hospitals and distributors looked overseas to fill the need.
In March 2020, just six shipping containers arrived in the U.S. with N95s in them, and almost all of those masks were for industrial use, not medical. By September 2020, orders had soared — in one month, almost 3,000 shipping containers of N95s arrived at U.S. ports, almost entirely medical-grade.
Federal officials saw the reliance on imports as a security problem and worked to boost domestic supply, The federal agency that oversees N95 manufacturers, the National Institute for Occupational Safety and Health, approved 94 new brands, including 19 new domestic manufacturers, according to the internal government emails.
Over the fall and winter, those domestic producers hired thousands of employees and invested millions in supplies to churn out masks.
As U.S. production rose through the fall and winter, imports plunged. Shipment data maintained by ImportGenius and Panjiva Inc., services that independently track global trade, shows arrivals dropped sharply to about 150 in January 2021.
In Shanghai, Cameron Johnson, a trade consultant at the Tidalwave Solutions recruitment firm and an adjunct business faculty member at New York University, says “the bottom has fallen out of the mask market.”
But the U.S. government failed to help link buyers to the growing supplies. Now some of those U.S.-based makers are facing major financial losses, potential layoffs and bankruptcies.
In December, Moeller, an appointee of President Donald Trump, grew frustrated while working in the office of CDC Director Dr. Robert Redfield.
“(NIOSH) had approved almost 20 U.S. manufacturers to make N95 masks, but had not published any guidance or notice of what is ultimately more than 100 million N95 mask-making capacity a month going unsold,” Moeller told the AP.
The Food and Drug Administration was monitoring N95 supply chains, and received $80 million in emergency pandemic funds “to prevent, prepare for and respond to coronavirus.” Of that amount, about $38 million was for efforts related to tracking medical product shortages.
But the agency has still not solved the problem. “There have been a good number of new NIOSH (mask) approvals that have been granted,” said Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships & Technology Innovation. “Yet the access to those new manufacturers, there seems to be a hurdle there. FDA … is trying to identify that blockage.”
Schwartz said the agency is working with President Joe Biden’s pandemic response team and the health care industry to find answers.
The internal emails show that Moeller in December alerted NIOSH head Dr. John Howard about the unused U.S. N95 manufacturing capacity.
In a Dec. 22 email, Howard acknowledged he was still hearing of shortages: “Apparently, there is a significant domestic production capacity going unused for the lack of orders and we have tried to address this supplier/purchaser disconnect.”
A few weeks later, as a suggested remedy, Howard said the list of domestic N95 manufacturers had now been published for potential buyers. But the list shows up on page 3 of an obscure newsletter published by a University of Cincinnati toxicologist, after a satirical column on “chin warmers,” or improperly worn surgical masks.
NIOSH was not actively promoting the new mask producers, Howard wrote, saying that “to avoid the perception of inequitable treatment and because of the dynamic production landscape, we have not posted information on our website regarding respirator availability.”
Howard, through an agency spokesperson, declined a request for an interview. In a statement, NIOSH also acknowledged “a supply and demand disconnect” exists and said it is working with FEMA and other federal agencies, as well as online sales platforms like Amazon.com Inc., to better connect purchasers with U.S.-made mask producers.
“How could this be happening? You have an obvious need, and you have a tremendous engine of supply,” said Tony Uphoff, president and CEO of Thomas, an online platform for product sourcing. Uphoff said that for decades the N95 market was stable, so when the virus upended the supply chain, procurement officers were unprepared to respond.
Meanwhile, the U.S. finds itself in a paradox. The more N95s are rationed to alleviate a perceived shortage, the fewer masks are actually reaching the front lines.
N95s still appear on the FDA shortage list, in part because of reports from doctors and nurses who say they still don’t have enough. The American Hospital Association also says there’s a scarcity of N95s, citing global demand. But the government shortage list triggers distributors to limit how many masks they can sell to each hospital.
“The concept is similar to when trading is halted on Wall Street,” said David Hargraves, senior vice president of supply chain for Premier, a group purchasing organization that helps buy equipment and supplies for thousands of hospitals across the U.S. “You put the protective allocation in place to prevent folks from hoarding and overbuying, therefore exacerbating the shortage situation.”
But without clear guidance, hospitals are left to make their own decisions.
Some procurement officers are loath to trust masks from unfamiliar suppliers. Others balk at federally approved domestic manufacturers, some of whom charge more than international makers. And adding new products into a hospital’s inventory can be tricky: Every health care worker must be fit-tested before using a new brand.
“It’s not easy to pivot from one brand to another,” said Katie Dean, health care supply chain director at Stanford Health Care in California, where they are back to using one N95 mask per patient, as needed.
Dr. Robert Hancock, an emergency room doctor and president of the Texas College of Emergency Physicians, said hospitals are taking risks by continuing to ration N95s, even when they have enough. He said some doctors tell him they get one N95 mask every five to seven days.
“All the N95s currently out there were designed to be worn once. They were never designed to be reused,” Hancock said. “Hospitals are going to have to come up with some hard data to back up that a mask built for single use is OK to use repeatedly if there are other masks available. It was one thing when we had no choice. But you can’t just say something works because it favors you financially.”